PRODUCT MANUAL
Table of Contents
Preparation for First Use
Warnings, Cautions, and Notes
Smartinhaler™ Sensor Components
Terms and Abbreviations
Compatible MDI Devices
Installing or Removing an MDI
Setting up Bluetooth® Communications
Delivering a Dose of Medication
Reminders
Reviewing Smartinhaler™ Sensor Usage Data
Manually Uploading Stored Information
Reviewing Battery Level
Recharging the Smartinhaler™ Sensor -
Rechargeable Sensor Only
Cleaning the Smartinhaler™ Sensor and MDI
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5
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6
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10
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12
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13
14
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Storage
Troubleshooting
Servicing
Disposal
Smartinhaler™ Sensor Intended Use
How the Smartinhaler™ Sensor Works
Safety and Usage Information
Symbols
Warranty
Specications
Smartinhaler™ Sensor Specications
FCC Statement
IC Statement
RF Exposure Statement
Declaration of Conformity
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Preparation for First Use
Rechargeable Sensor - NF0090
Following manufacture the Smartinhaler™ sensor is
placed in Deep-Sleep mode to conserve battery life.
Before rst use, place the Smartinhaler™ sensor on charge
for a minimum of 3 hours or until the LED stops ashing
green. This will wake the Smartinhaler™ sensor from DeepSleep mode and the Smartinhaler™ sensor is ready to use.
Non-Rechargeable Sensor - NF0091
Following manufacture, the Smartinhaler™ sensor is
placed in Deep-Sleep mode to conserve battery life.
To wake up the Smartinhaler™ sensor, hold down the
Status Button for 3 seconds and then release. Press
the Status Button once more to check the battery level.
The Smartinhaler™ sensor LED should ash green prior
to rst use.
Warnings, Cautions, and Notes
Warnings identify actions or situations that could
lead to personal injury. Take note of all warnings
before using the Smartinhaler™ sensor.
Cautions identify actions or situations that
could damage the Smartinhaler™ sensor or other
equipment, or affect the accuracy or availability of
recorded actuation data.
Notes contain advisory information about some
aspect of the Smartinhaler™ sensor or its use.
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Smartinhaler™ Sensor Components
Key:
1. Use only with this medication
2. Light Emitting Diode (LED)
3. Battery type – see Symbols section for more information
4. Status Button (reminder button/battery check button)
5. USB port (only used for NF0090 to recharge battery)
Terms and Abbreviations
MDI Metered Dose Inhaler.
Compatible MDI Devices
The Smartinhaler™ sensor is designed to work
only with the MDI and medication indicated on the
Smartinhaler™ sensor label.
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Installing or Removing an MDI
Installation (for non-tethered MDI)
To install the Smartinhaler™ sensor, align the MDI with
the back of the Smartinhaler™ sensor. Push the MDI
rmly into the Smartinhaler™ sensor, ensuring the
mouth piece of the MDI goes through the front window
on the Smartinhaler™ sensor.
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Removal (for non-tethered MDI)
While holding each side of the Smartinhaler™ sensor,
gently push the mouthpiece of the MDI to remove the
MDI from the Smartinhaler™ sensor.
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Installation (for tethered MDI)
To install the Smartinhaler™ sensor, open the MDI cap,
and align the MDI with the back of the Smartinhaler™
sensor. Push the MDI rmly into the Smartinhaler™
sensor, ensuring the mouth piece of the MDI goes
through the front window on the Smartinhaler™ sensor.
Close the MDI cap.
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Removal (for tethered MDI)
Open the MDI cap. While holding each side of the
Smartinhaler™ sensor, gently push the mouthpiece of
the MDI to remove the MDI from the Smartinhaler™
sensor. Close the MDI cap.
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Setting Up Bluetooth® Communications
The Smartinhaler™ sensor must be paired with a
compatible Bluetooth® smartphone or tablet computer
in order to upload stored usage data. Refer to
Smartinhaler™ App on App store or on Google Play
for more information. To pair the Smartinhaler™ sensor
with a smartphone or tablet computer:
1. Follow the instructions on your smartphone or tablet
computer to put it in pairing mode.
2. On the Smartinhaler™ sensor press the Status
Button 3 times quickly to enter pairing mode. The
LED will ash blue when the Smartinhaler™ sensor is
in pairing mode.
3. Follow any prompts on your smartphone or tablet
computer to select and accept pairing with the
Smartinhaler™ sensor. The LED will ash green to
indicate pairing is successful.
If pairing is not successful within 60 seconds the
LED will ash red. The pairing process can be
repeated if necessary.
The Smartinhaler™ sensor can only be paired with
a single smartphone or tablet computer at a time.
Starting the pairing process removes the current
paired Smartinhaler™ sensor.
Delivering a Dose of Medication
Refer to the labelling provided with the inhaler for
instructions on use. Carry out all steps required to use
your inhaler according to the instructions.
The Smartinhaler™ sensor LED ashes after detecting a
medication dose has been actuated.
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This manual does not provide information on
how to use compatible MDI medication and is
not intended to replace the advice provided by
a healthcare professional. Directions for using
compatible medication should be obtained from a
healthcare professional and followed accordingly.
Any questions related to prescription medication
should be referred to a healthcare professional.
To use the Smartinhaler™ sensor with a spacer, hold the
Smartinhaler™ sensor in one hand with the thumb at the
base of the Smartinhaler™ sensor and the index nger
and second nger on top of the medication canister.
Use the other hand to support the spacer chamber.
The Smartinhaler™ sensor LED ashes after detecting a
medication dose has been actuated.
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Reminders
Audio-visual reminders can be set up from a
Smartinhaler™ app.
If enabled, the medication reminders are generated with
increasing frequency for up to 24 minutes until either
the prescribed medication dose is taken or the reminder
is cancelled. The LED always ashes green when the
reminder activates.
To cancel the reminder, hold down the status button
until the LED ashes red. There will be a beep sound
along with the red ash to notify that the reminder is
now cancelled.
Reviewing Smartinhaler™ Sensor
Usage Data
The MDI usage history can be automatically uploaded
via a compatible paired smartphone or tablet computer.
The upload of new information will occur automatically
as long as the Smartinhaler™ sensor is within range (5
meters or 16 feet) of the smartphone or tablet computer.
When travelling ensure your communications
device is set to the local time zone for accuracy of
MDI actuation logs.
Manually Uploading Stored Information
To ensure all current data has been transferred, the
Smartinhaler™ sensor can manually upload information
to a paired Bluetooth® smartphone or tablet computer.
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To manually upload stored usage data from the
Smartinhaler™ sensor
1. Hold down the Status Button until the LED shows
white, then release.
2. The LED will ash white while the Smartinhaler™
sensor attempts to upload, then ash green if the
upload is successful.
The Smartinhaler™ sensor LED will ash red if the upload
is not successful. Check the Smartinhaler™ sensor is
within range of the paired smartphone or tablet computer,
and ensure that Bluetooth® communications enabled.
Reviewing the Battery Level
The LED on the main face indicates the battery level of
the Smartinhaler™ sensor after medication is actuated,
or when the Status Button is pressed:
Colour Meaning
The battery level is good, and the
Green
Smartinhaler™ sensor is monitoring actuations.
The battery level is getting low. The Smartinhaler™
Orange
sensor is still monitoring actuations.
The battery is dead. The Smartinhaler™
Red
sensor has stopped monitoring actuations.
The battery is dead, or the Smartinhaler™
No
sensor has failed, e.g. due to liquid
Flash
immersion or mechanical stress.
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Recharging the Smartinhaler™ Sensor NF0090 only
The Smartinhaler™ sensor contains an internal
rechargeable battery and is recharged via the USB
port. To recharge the Smartinhaler™ sensor, connect
it to a computer USB port or USB wall plug adaptor,
using the supplied connector.
When connected to a charging source, the LED will ash
slowly according to the battery level. When charging is
complete, the LED will stop ashing. The Smartinhaler™
sensor should not be used while charging.
Allow up to 3 hours to fully recharge a Smartinhaler™
sensor that is displaying a red ashing LED.
The Smartinhaler™ sensor should be recharged
every 4 months as a minimum to ensure continued
battery function.
Cleaning the Smartinhaler™ Sensor and MDI
Check the instructions from the MDI manufacturer for
keeping the mouthpiece clean. Keep the Smartinhaler™
sensor clean and free of chemicals, steam, water and
dust. Clean the outside plastic enclosure with a lightly
dampened cloth. Check the Smartinhaler™ sensor is
clean and repeat if necessary. Leave it to dry in a warm
place that is less than 30°C (86°F).
The Smartinhaler™ sensor is battery-powered and
electronic. Do not immerse the Smartinhaler™
sensor in water. Do not use the Smartinhaler™
sensor if it is not in good condition.
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Storage
To help maintain battery capacity, store your
Smartinhaler™ sensor below 30°C (86° F). Keep out of
direct sunlight and avoid extreme temperatures.
Troubleshooting
If the Smartinhaler™ sensor is not responding to
Bluetooth® communications, check the Smartinhaler™
sensor battery level as per Reviewing the Battery Level
in this manual.
Other wireless communications equipment such
as wireless home network devices, mobile phones,
cordless telephones and their base stations, and
walkie-talkies can affect the Smartinhaler™ sensor, and
should be kept at least 30cm (12in) away.
Increase the separation distance between the
Smartinhaler™ sensor and any such devices if this
could be causing problems.
If this does not help, contact the supplier or
manufacturer for further assistance.
Customer Support
For support on this product, email us at
support@smartinhaler.com or call us on +64 9 307 2771.
For information about your medical condition, please
speak to your healthcare provider directly.
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Servicing
Please contact the supplier or manufacturer for
Smartinhaler™ sensor servicing. Do not attempt to
open or service the Smartinhaler™ sensor. Tampering
with the Smartinhaler™ sensor voids the warranty.
Disposal
Dispose or recycle the Smartinhaler™ sensor in
accordance with regulations for your country, as
applicable for electronic devices containing a lithium
polymer or lithium primary battery. Ensure that the
inhaler is removed from the Smartinhaler™ sensor prior
to disposal.
EU only: Do not dispose of the Smartinhaler™ sensor
as unsorted municipal waste. The Smartinhaler™ sensor
must be recycled in accordance with Directives 2012/19/
EU and 2006/66/EC. To arrange for return or disposal of
the Smartinhaler™ sensor contact your local supplier.
Smartinhaler™ Sensor Intended Use
The Smartinhaler™ sensor is intended for single
patient use as a medication reminder and electronic
data capture accessory for recording actuations
of prescribed MDI usage. This may be used in the
following applications:
• In clinical trials, where researchers need to know when
a patient has actuated their trial MDI medication.
• In clinical practice, where specialists, general
practitioners, nurses, and educators need to know if a
patient has actuated their prescribed MDI medication.
• In self-management, where patients need to track
their medication use as part of their management plan
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The intended MDI is specied on the product label.
The Smartinhaler™ sensor is not intended to indicate
remaining quantity of medication in an MDI and does
not include a dose counting function.
How the Smartinhaler™ Sensor Works
The Smartinhaler™ sensor is a small battery-powered
electronic data logger that attaches to an MDI. The
Smartinhaler™ sensor contains an electronic clock and
calendar that is used to log the date and time of MDI
actuation. The Smartinhaler™ sensor registers MDI
actuations. Usage data can be uploaded via a wireless
Bluetooth® connection.
Safety and Usage Information
To ensure your inhaler functions correctly, do
not use the Smartinhaler™ sensor with any other
MDI or medication than that indicated on the
Smartinhaler™ sensor label.
The Smartinhaler™ sensor does not contain a
dose counter. Do not use data collected by the
Smartinhaler™ sensor to determine the number of
doses remaining in a medication canister.
Smartinhaler™ sensor is not intended to diagnose
your condition or to replace the diagnosis of a
licensed physician.
For hygiene and data integrity reasons, do not
use the Smartinhaler™ sensor with more than
one patient.
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Take care to not spill liquids on the Smartinhaler™
sensor or immerse it in water.
The Smartinhaler™ sensor does not record the
quantity of medication delivered by the MDI.
Symbols
Manufacturer: Adherium (NZ) Ltd
Serial Number
Year of Manufacture
Keep dry
Rechargeable Sensor
Non-rechargeable Sensor
EU only: Do not dispose Smartinhaler™ sensor
as unsorted municipal waste
Warranty
The Smartinhaler™ sensor includes a 12 month
warranty against manufacturing defects from date
of rst use. This warranty maybe voided under the
following circumstances: damage to the Smartinhaler™
sensor including dropping, water damage resulting
from condensation or immersion, tampering, attempts
to service, or other forms of abuse.
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The Smartinhaler™ sensor warranty expires 4 years
from date of manufacture.
Specications
Model numbers
Actuation Log
Precision
Actuation Log
Capacity
Internal Clock
Accuracy
Compatible with
Wireless
Technology
Operating
Temperature
Storage
Temperature
Operating /
Storage Humidity
NF0090, NF0091
1 second
5120 actuations and sensor
status records
± 1 hour after 12 months.
Note: the Smartinhaler™
sensor clock is updated every
time data is uploaded.
iOS or Android smartphone and
tablet devices. Refer to Apple
App store or Google Play store
for more information.
Bluetooth® 4.0: 2.40 - 2.48
GHz, 2.5 mW Low Energy
0 to 40ºC (32 to 104ºF)
-20 to 60ºC (-4 to 140ºF)
15 to 90% RH (non-condensing)
at water vapour pressure ≤ 50 hPa
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Smartinhaler™ Sensor Specications
Rechargeable Sensor
Model Number
Battery Type
Shelf Life
Service Life
Non-rechargeable Sensor
Model Number
Battery Type
Shelf Life
Service Life
FCC Statement
The Smartinhaler™ sensor complies with Part 15 of
the FCC Rules. Operation is subject to the following
two conditions:
1. The Smartinhaler™ sensor may not cause harmful
interference, and
2. The Smartinhaler™ sensor must accept any
interference received, including interference that
may cause undesired operation.
The Grantee is not responsible for any changes or
modications not expressly approved by the party
responsible for compliance. Such modications could
void the user’s authority to operate the equipment.
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NF0090
Lithium Polymer
2 years
2 years
NF0091
Lithium Primary
3 years
1 year
IC Statement
(Non-Rechargeable Sensor Only - NF0091)
The Smartinhaler™ sensor complies with Industry
Canada’s license-exempt RSSs. Operation is subject
to the following two conditions:
1. The Smartinhaler™ sensor may not cause
interference; and
2. This Smartinhaler™ sensor must accept any
interference, including interference that may cause
undesired operation of the sensor.
Le présent appareil est conforme aux CNR d’Industrie
Canada applicables aux appareils radio exempts
de licence. L’exploitation est autorisée aux deux
conditions suivantes:
1. l’appareil ne doit pas produire de brouillage, et
2. l’utilisateur de l’appareil doit accepter tout
brouillage radioélectrique subi, même si le
brouillage est susceptible d’en compromettre
le fonctionnement.
RF Exposure Statement
This equipment complies with the RSS-102 radiation
exposure limits set forth for an uncontrolled environment.
Declaration of Conformity
Adherium (NZ) Ltd declares that this Smartinhaler™
sensor is in compliance with the essential requirements
and other relevant provisions of Directive 93/42/EEC.
Email contact@smartinhaler.com for a copy of the
declaration of conformity.
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Hereby, Adherium (NZ) Ltd declares that the radio
equipment type Smartinhaler™ sensor is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is
available at the following internet address:
www.smartinhaler.com/RDC
No part of this document may be reproduced or
transmitted in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise,
without the prior written permission of Adherium (NZ) Ltd.
Product specications may change without notice.
Patent/Design Notice -TBC
Emergo Europe
Prinsessegracht 20
2514 AP The Haque,
The Netherlands
Australian Sponsor
Adherium Ltd
Level 14, 140 William Street
Melbourne
Victoria 3000
Australia
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Smartinhaler™ is manufactured by:
Adherium (NZ) Ltd
Level 2, 204 Quay Street
Auckland 1010
New Zealand
Smartinhaler™ Product Manual
Part Number: ND0400
Version: 1
Issue Date: 19 Jan 2018
All product names and brand names in this document
are trademarks or registered trademarks of their
respective holders.
© Copyright Adherium (NZ) Ltd 2018. All rights reserved.
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Customer Support
For support on this product, email us at
support@smartinhaler.com or call us on
+64 9 307 2771. For information about your
medical condition, please speak to your
healthcare provider directly.
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